Stay Compliant from Day One

FDA regulations for cosmetics and personal care products are non-negotiable. Getting this wrong can result in recalls, fines, and damage to your brand.

What This Means For Your Brand

Regulatory compliance is not a bureaucratic inconvenience — it is the foundation of consumer trust. When customers use your product, they are trusting you to have done the work of ensuring it is safe, accurately labeled, and manufactured under controlled conditions. Brands that cut corners on compliance expose their customers to risk and themselves to regulatory action, retailer delistings, and reputational damage that is very difficult to recover from.

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) significantly expanded the FDA's authority over cosmetics and personal care products. Facility registration, product listing, adverse event reporting, and safety substantiation requirements are now enforceable by law. Brands that built their compliance practices before MoCRA are well-positioned; brands that have not need to assess their current practices against the new requirements immediately.

Compliance is also a commercial differentiator, particularly in retail channels. Major retailers including Sephora, Ulta, and Target have their own compliance requirements on top of FDA regulations — clean ingredient lists, specific prohibited substances, and documentation requirements. Building compliance into your product development process from the beginning means you will be retail-ready without expensive reformulations later.

FDA Labeling Requirements

The FDA mandates specific elements on every cosmetic label: the product identity statement, net quantity of contents, name and address of the responsible company, and the ingredient list in descending order of predominance using INCI names. Missing or incorrect label elements can trigger Warning Letters, import holds, and forced recalls — all of which are expensive and damaging to your brand.

GMP Compliance

Good Manufacturing Practice standards set the baseline for how cosmetics should be manufactured, tested, and stored. GMP compliance is not yet legally mandatory for all cosmetics in the US, but it is increasingly expected by major retailers, and the Modernization of Cosmetics Regulation Act (MoCRA) of 2022 is bringing new facility registration and safety substantiation requirements into effect.

International Regulations

If you plan to sell outside the US, each market has its own regulatory framework. The EU Cosmetics Regulation is among the most stringent in the world, requiring a Safety Assessment by a qualified professional and a Product Information File for every SKU. Canada, Australia, Japan, and China all have their own notification and ingredient restrictions that must be addressed before import.

How We Support This Step

Our facility operates under GMP standards and is registered with the FDA. Every formula we develop is reviewed for ingredient compliance against the FDA's list of prohibited and restricted substances, as well as common retailer clean beauty standards. We provide complete INCI ingredient lists in the correct format for US label compliance.

We maintain comprehensive batch records, ingredient documentation, and testing records for every product we manufacture. This documentation is essential for MoCRA compliance and is available to our clients to support their regulatory obligations. We can also facilitate introductions to cosmetic regulatory consultants for brands that need specialist support for international market entry.